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Health Canada Medical devices

Soltive Superpulsed Laser Ball Tip Fiber Single Use

Issued June 7, 2022
Issue
Olympus has received a limited number of complaints that the laser fiber size on the label did not match the product's size. These complaints were identified by users during preparation for use. Olympus investigations confirmed that the model and size of laser fibers may be mismatched between the product's carton (box of 5), immediate pouch packaging and/or the device. One lot number was sold in Canada. Recall start date: May 26, 2022
Hazard description
Labelling and packaging
Product
Product name
Soltive Superpulsed Laser Ball Tip Fiber Single Use
Reference
ID
RA-64242